Companion Diagnostics

Home / Diagnostic Services /

Almac Diagnostic Services is uniquely placed to partner with clients throughout the entire process of Companion Diagnostics (CDx) development.

From the fundamental research and discovery phase, to development and validation, conducting clinical trials and the manufacturing of test kits or lab developed tests, to patient sample testing.  With expert supporting services teams in Design Control, Project Management, Data Sciences and Quality & Regulatory Affairs we ensure that your individual program objectives are met on time, within budget and to high quality standards.

Almac Group has 50 years of manufacturing and global distribution experience to support your CDx commercialization needs.

Almac Diagnostic Services commercialization team will partner early with your commercial team to ensure your assay will be suitable for the target market. Our teams agree a joint commercialization plan and work in partnership throughout the lifecycle of the product.

Almac Diagnostic Services can offer multiple flexible CDx commercialization models for BioPharma clients to choose from: Single Site Model, IVD Kit Model or IVD Kit Hybrid model (with bridging).

We offer:

Design Control & Risk Management

Sample Sourcing

Assay Development & Validation

Assay Software Development

Single Site Test Capability

IVD Kit Manufacturing Capability

Regulatory Submissions in Multiple Territories

Clinical Support

Commercialization Readiness

This website uses cookies. By continuing to browse the site, you are agreeing to our use of cookies